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Sponsors and Collaborators: |
Department of Defense National Institute of Mental Health (NIMH) |
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Information provided by: | Walter Reed Army Medical Center |
ClinicalTrials.gov Identifier: | NCT00662415 |
Almost everyone who has a traumatic limb amputated will experience a phantom limb - the vivid impression that the limb not only still is present, but also in many cases, painful. Preliminary data from study WRAMC WU# 05-71034, "Pilot study to assess the efficacy of mirror-box and mental visualization treatments on phantom limb pain" demonstrates that 4 weeks of mirror therapy is effective for treating phantom limb pain (PLP) and suggests that vision is a key component modulating PLP and may be the explanation for the efficacy of mirror therapy, as subjects view the reflected image of their intact limb while attempting to move the amputated, or phantom, limb. We propose conducting a study using functional magnetic resonance imaging (fMRI) to identify brain regions critical for the mirror effect and to study the relationship of visual activation to the sensation of phantom pain. Subjects will have an fMRI scan prior to starting therapy, 2 weeks after starting mirror therapy and again after 4 weeks of mirror therapy. Data will be gathered daily on the number of episodes of phantom limb pain, the average length of episodes, and the average intensity of pain.
Condition | Intervention |
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Phantom Limb Pain |
Device: mirror-box treatment Behavioral: observation |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | Study Using Functional MRI to Examine Changes in the Brain in Unilateral Lower Limb Amputees Treated With Mirror Therapy for Phantom Limb Pain. |
Estimated Enrollment: | 42 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
12 non-amputee control subjects will be scanned at 0, 2 and 4 weeks but will not recieve mirror therapy.
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Behavioral: observation
observation
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2: Experimental
24 unilateral lower extremity amputee subjects will recieve daily mirror therapy for phantom limb pain and will be scanned at 0, 2, and 4 weeks.
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Device: mirror-box treatment
15 minutes daily for 4 weeks
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
For Amputee Subjects:
For Control Subjects:
Exclusion Criteria:
For Amputee Subjects:
For Control Subjects:
Contact: Jack W Tsao, MD | (301) 295-9684 | tsaoj@grc.nia.nih.gov |
Contact: Christopher Baker, PhD | (301) 435-6058 |
United States, District of Columbia | |
Walter Reed Army Medical Center | Recruiting |
Washington, District of Columbia, United States, 20307 | |
Contact: Jack W Tsao, MD 301-295-9684 tsaoj@grc.nia.nih.gov | |
United States, Maryland | |
National Institutes of Health | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: Christopher Baker, PhD 301-435-6058 |
Study ID Numbers: | DCI-0771043 |
Study First Received: | March 14, 2008 |
Last Updated: | April 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00662415 |
Health Authority: | United States: Federal Government |
phantom limb pain fMRI mirror therapy |
Signs and Symptoms Neurologic Manifestations Pain |
Phantom Limb Neurobehavioral Manifestations Perceptual Disorders |
Nervous System Diseases |